Home NDC 72664-217-01 Ursodiol
Product NDC 72664-217
Requested package NDC 72664-217-01
11-digit product format 726640217
Labeler code 72664
Product ID 72664-217_062ebe65-b4e7-2fb9-e063-6294a90a5caa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ursodiol
Dosage form CAPSULE
Route ORAL
Labeler VGYAAN Pharmaceuticals LLC
Application ANDA214329
Marketing category ANDA
Marketing start 2020-10-25
Substance URSODIOL
Active strength 300 mg/1
Pharmacologic classes Bile Acid [EPC], Bile Acids and Salts [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214329-001 URSODIOL URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214329-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214329-001 URSODIOL 300MG CAPSULE / ORAL 2021-07-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214329-001 URSODIOL 300MG CAPSULE / ORAL 2021-07-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214329-001 URSODIOL 300MG CAPSULE / ORAL 2021-07-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214329-001 URSODIOL 300MG CAPSULE / ORAL 2021-07-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214329-001 URSODIOL 300MG CAPSULE / ORAL 2021-07-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214329-001 URSODIOL 300MG CAPSULE / ORAL 2021-07-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214329-001 URSODIOL 300MG CAPSULE / ORAL 2021-07-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214329-001 URSODIOL 300MG CAPSULE / ORAL 2021-07-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214329-001 URSODIOL 300MG CAPSULE / ORAL 2021-07-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Ursodiol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength URSODIOL 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 724L30Y2QR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 858747 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72664-217-01 Ursodiol 100 in 1 BOTTLE, PLASTIC CAPSULE 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72664-217 URSODIOL CAPSULE [VGYAAN PHARMACEUTICALS LLC] 5 Current NDC, Legacy NDC, 1 package rows 20230926_db43354d-4d77-4241-af4e-5cfa6f6cd296.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72664-217-01 72664021701 100 CAPSULE in 1 BOTTLE, PLASTIC (72664-217-01) 100 capsule 2020-10-25 0000-00-00 No No Current